Acute PancreatitisPhase 3crepsmt1NCT01060826
Efficacy of Administration of Somatostatin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
A Phase 3 study testing fisiologic serum, somatostatin, intravenous bolus and somatostatin in people with Acute Pancreatitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- fisiologic serum, somatostatin, intravenous bolus and somatostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 2 sitesSpain
- Study dates
- May 2009to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
Who cannot join
- Pregnancy or history of allergy to somatostatin.
- Acute myocardial infarction within 3 months of the procedure.
- Acute pancreatitis in patients undergoing early ERCP in the acute phase of the disease.
- Previous sphincterotomy.
- Chronic pancreatitis.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Endoscopy Unit Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Carlos Guarner, cguarner@santpau.cat
Cristina Gómez
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Cristina Gómez, 620936011, cgomezo@santpau.cat
Cristina Gómez
About this study
Official title: Randomized, Double-blind Study to Evaluate the Efficacy of Administration With Intravenous Bolus Followed by a Continuous Infusion of Somatostatin in the Prevention of Post-ERCP Pancreatitis
Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
Read the detailed description
A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
- Conditions
- Acute Pancreatitis
- Being tested
- fisiologic serum, somatostatin, intravenous bolus, somatostatin
- Keywords
- acute pancreatits
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fisiologic serumOther
250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure
somatostatin, intravenous bolusDrug
250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic
somatostatinDrug
Intravenous bolus 250 micrograms
| Study group | Role | What they receive |
|---|---|---|
| somatostatin, intravenous bolus | Experimental | A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. Receives: Drug: somatostatin, intravenous bolus; Drug: somatostatin |
| Placebo, intravenous bolus | Placebo comparator | A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. Receives: Other: fisiologic serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute post-ERCP pancreatitis
Measured: One week
Secondary outcomes (1)
Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Cristina Gómez, Principal investigator, Endoscopy Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060826
- Sponsor's protocol ID
- 2008-003338-41
- Other IDs
- 2008-003338-41, 2008
- Acronym
- crepsmt1
- Status last verified
- Jun 2011
- First submitted
- 28 Jan 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 2. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004;59:845-64. 3. Bordás JM et al. Effects of bolus somatostatin in preventing pancreatitis after endoscopic pancreatography: results of a randomized study. Gastrointest Endosc 1998;47:230-4. 4. Poon RT, Yeung C, Liu CL, et al. Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomized controlled trial. Gut 2003;52:1768-73. 5. Andriulli A et al. Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis. Gastrointest Endosc. 2000;5:1-7.
Concepcion-Martin M, Gomez-Oliva C, Juanes A, Diez X, Prieto-Alhambra D, Torras X, Sainz S, Villanueva C, Farre A, Guarner-Argente C, Guarner C. Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial. Endoscopy. 2014 Oct;46(10):851-6. doi: 10.1055/s-0034-1377306. Epub 2014 Jun 30.
PubMed 24977398
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Study to Evaluate the Efficacy of Administration With Intravenous Bolus Followed by a Continuous Infusion of Somatostatin in the Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT01060826
- Acronym / sponsor ID
- crepsmt1 / 2008-003338-41
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatits
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute pancreatitis is the most frequent (5-10%) and severe complication after endoscopic retrograde cholangiopancreatography (ERCP), that could require of surgical intervention and lead to death. A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
Detailed description
A double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. The main aim of this study will be the incidence of acute post-ERCP pancreatitis and secondary objectives will be identify sub-groups of patient with high risk to develop post-ERCP pancreatitis, who could benefit of pharmacologic prophylaxis before the exploration. The study will include 510 patients submitted to an ERCP during a period of 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somatostatin, intravenous bolus | Experimental | Drug: somatostatin, intravenous bolus, Drug: somatostatinA double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. |
| Placebo, intravenous bolus | Placebo comparator | Other: fisiologic serumA double- blind study designed to evaluate if the treatment with somatostatin in intravenous bolus before starting the ERCP procedure followed by a continuous infusion for 4 hours after endoscopic proof could prevent acute post-ERCP pancreatitis. Patients submitted to ERCP will be randomized in two groups of treatment, one will receive somatostatin and another placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
Key exclusion criteria (5 listed)
- Pregnancy or history of allergy to somatostatin.
- Acute myocardial infarction within 3 months of the procedure.
- Acute pancreatitis in patients undergoing early ERCP in the acute phase of the disease.
- Previous sphincterotomy.
- Chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fisiologic serum250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure | Other | Placebo, intravenous bolus |
| somatostatin, intravenous bolus250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic | Drug | somatostatin, intravenous bolus |
| somatostatinIntravenous bolus 250 micrograms | Drug | somatostatin, intravenous bolus |
Primary outcome
The incidence of acute post-ERCP pancreatitis
Time frame: One week
1 secondary outcome
Identify sub-groups of patients with high risk to develop post-ERCP pancreatitis
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
- Background1. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 2. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004;59:845-64. 3. Bordás JM et al. Effects of bolus somatostatin in preventing pancreatitis after endoscopic pancreatography: results of a randomized study. Gastrointest Endosc 1998;47:230-4. 4. Poon RT, Yeung C, Liu CL, et al. Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomized controlled trial. Gut 2003;52:1768-73. 5. Andriulli A et al. Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis. Gastrointest Endosc. 2000;5:1-7.
- Derived from this study: PubMed 24977398Concepcion-Martin M, Gomez-Oliva C, Juanes A, Diez X, Prieto-Alhambra D, Torras X, Sainz S, Villanueva C, Farre A, Guarner-Argente C, Guarner C. Somatostatin for prevention of post-ERCP pancreatitis: a randomized, double-blind trial. Endoscopy. 2014 Oct;46(10):851-6. doi: 10.1055/s-0034-1377306. Epub 2014 Jun 30.
- preventing post-therapeutic ERCP pancreatitisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Gómez principal investigator
Endoscopy Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fisiologic serum, somatostatin, intravenous bolus and somatostatin in people with Acute Pancreatitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute post-ERCP pancreatitis (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.